Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma

Lymphoma Clinical Trial

Official title: A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-cell Lymphomas

Status Completed

Clinical Trial Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced or recurrent lymphoma.

Clinical Trial Description

OBJECTIVES:

• Determine the safety and tolerability of monoclonal antibody HuM291 in patients with advanced or recurrent CD3+ T-cell lymphomas.

• Evaluate the pharmacokinetics and pharmacodynamics of this treatment regimen in this patient population.

• Determine the response in these patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of unacceptable toxicity. Patients achieving a partial response, complete response with recurrence, or stable disease may receive further therapy.

Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed weekly for 1 month and then monthly for 3 months.

PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Small Intestine Cancer

• NCT number: NCT00006009
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 1
• Start date: April 2001
• Completion date: October 2003